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Efficacy and safety of newer SGLT2 and DPP-IV inhibitors, when given in single pill as combinations versus given as separate pills together, in type 2 diabetes on Metformin

Efficacy and safety of Fixed dose combinations of newer SGLT2 and DPP-IV inhibitors versus therapy with each mono-component, in poorly controlled type 2 diabetes on Metformin: A Randomized open-label trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049730
Enrollment
200
Registered
2023-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Dapagliflozin Vildagliptin FDC with Metformin: Dapagliflozin + Vildagliptin(10+100)+ Metformin 1000 orally once daily for 6 months Control Intervention1: Dapagliflozin, vildagliptin and

Sponsors

Jawaharlal Nehru Medical college, Aligarh Muslim University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age >= 18 years Diagnosis of type 2 diabetes On metformin dose (>=1000 mg/d) HbA1c >=8 to 10.0% Fasting plasma glucose (FPG) Exclusion criteria

Exclusion criteria

Exclusion criteria: Type 1 diabetic patient and patient on Insulin Pregnancy, diabetic ketoacidosis A cardiovascular event in the 3 months before enrolment. Moderate or severe impairment of renal function (estimated glomerular filtration rate (eGFR) of

Design outcomes

Primary

MeasureTime frame
Mean change in HbA1c from baselineTimepoint: Mean change in HbA1c from baseline, 12 weeks and 24 weeks—

Secondary

MeasureTime frame
fasting plasma glucose (FPG)Timepoint: From baseline to week 12 and 24;mean change in systolic and diastolic BPTimepoint: from baseline to week 12 and 24;postprandial blood sugar(PPBS)Timepoint: from baseline to week 12 and 24;The proportion of participants achieving a therapeutic glycemic response HbA1cless than 7.0%Timepoint: at 24 weeks;Total body weightTimepoint: from baseline to week 12 and 24—

Countries

India

Contacts

Public ContactShemeer PS

Jawaharlal Nehru Medical College, Aligarh Muslim university

dr.farhan.k@gmail.com9759468300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026